MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/65

Device Problems Difficult to Remove (1528); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During initial implant procedure, while trying to position the right ventricular (rv) lead the helix was unable to be retracted and the stylet was unable to be removed.The physician suspected that the cause was due to difficult patient anatomy and that blood had got inside the rv lead.The rv lead was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported events of difficulty retracting the helix and stylet stuck inside the lead were confirmed.As received, a complete lead was returned in one piece.The stylet that was used in the field was not returned with the lead.The helix was retracted and clogged with blood/tissue.X-ray examination showed the inner coil at the connector region was overtorqued consistent with procedural damage which contributed to the reported event of stylet stuck inside the lead.Stylet insertion test was performed, and a restriction was noted at the connector region.After cleaning, the helix could be extended and retracted.The full helix extension length was measured to be within specification.The cause of the reported events was isolated to the helix being clogged with blood/tissue and overtorqued inner coil at the connector region.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10677613
• MDR Text Key: 211269197
• Report Number: 2938836-2020-08718
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 7122Q/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: S000077579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1